Sterile fluid collection tube package

ABSTRACT

Various technologies presented herein relate to sterile transport, storage and operation of fluid collection tubes. A plurality of sterile sample tube packages are presented, wherein each package comprises a tray (having a recessed cavity formed therein), one or more fluid collection tubes and a cover. Each cavity includes at least one compartment, wherein a collection tube can be respectively stored in each compartment. The tray and cover can be formed from medically sterile materials.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.14/992,631, filed on Jan. 11, 2016, and entitled “STERILE FLUIDCOLLECTION TUBE PACKAGE”, which claims priority to U.S. ProvisionalPatent Application No. 62/102,683, filed on Jan. 13, 2015, and entitled“BLOOD COLLECTION TUBES STERI-PACK”, the entireties of which areincorporated herein by reference.

BACKGROUND

Collection tubes are commonly utilized in the medical/veterinary fieldsto enable collection and storage of fluids (e.g., blood, plasma, etc.).However, such tubes can be fragile and care must be taken in order topackage the tubes for safe transportation, storage, and sale.

Blood collection tubes are commonly sold in packs of 40 to 100 units.Conventionally, blood collection tubes oftentimes are packaged using anopen foam, cardboard, or plastic base (e.g., a tray) with a wrap filmcover. Such packaging can be satisfactory in the case of bloodcollection tubes for medical use, e.g., in a laboratory, medicalfacility, dental facility, etc. However, when the cover is removed toopen the package to enable removal of one or more of the tubes for usewith a patient, the remaining unused tubes are subsequently kept in anopen environment (e.g., the laboratory environment) for further use withother patients. This open storage enables airborne and crosscontamination of the exterior parts of the remaining unused tubes, whichcan lead to false results, etc.

SUMMARY

The following is a brief summary of subject matter that is described ingreater detail herein. This summary is not intended to be limiting as tothe scope of the claims.

Described herein are various technologies that relate to steriletransport, storage, and operation of fluid collection tubes. Variousembodiments presented herein relate to a sterile fluid collection tubepackage for storage of one or more fluid collection tubes, wherein thefluid collection tubes can be utilized in the collection and storage offluids (e.g., blood, plasma, etc.). The sterile fluid collection tubepackage comprises a tray for location and storage of the one or morefluid collection tubes. The tray comprises a flange surrounding arecessed portion, wherein the recessed portion of the tray comprises oneor more non-retentive cavities (compartments). Each cavity isrespectively configured to store a respective fluid collection tube inthe plurality of fluid collection tubes. In an embodiment, neighboringcavities can be separated by a raised portion (a wall) of the recessedregion. A cover can be located on, and adhered to, the flange to coverthe recessed portion and any fluid collection tubes located therein. Tofacilitate removal of the one or more fluid collection tubes from thetray, the cover can be removed (e.g., peeled back) to expose the one ormore fluid collection tubes. During removal of the cover, the tray canbe inverted such that the one or more fluid collection tubes drop out(e.g., under the force of gravity) for subsequent retrieval and/orusage.

The tray, and recess cavity, can be formed by any suitable process. Inan embodiment, the tray can be a thermoformed tray. According to thisembodiment, the tray can be thermoformed from sheet stock, e.g., therecessed cavity is thermoformed in the sheet stock. In anotherembodiment, the tray can be formed by an injection molding process. Thetray can be formed from a sterile material. Suitable materials for thetray include a synthetic resin, a sterile foam, polyurethane,polyethylene terephthalate (PET), polyvinyl chloride (PVC), polyester, acombination thereof, etc. The cover can also be formed from a sterilematerial. The cover material can be at least one of paper, reinforcedpaper, synthetic reinforced paper, polyethylene terephthalate (PET),polyethylene terephthalate glycol-modified (PET-G), amorphous PET(A-PET), recycled PET (rPET), high impact polystyrene (HIPS), polyvinylchloride (PVC), polyethylene (PE), high density PE, polypropylene (PP),metal foil, TYVEK, TYVEK 2FS, BAREX, TRITON, etc. Further, any suitablebonding process can be utilized to attach the cover to the flange of thetray, e.g., thermo-bonding, adhesive, etc. Where an adhesive isutilized, the adhesive can have a composition to enable the cover to beresealed to the tray after removal of the one or more fluid collectiontubes located therein (e.g., for subsequent fluid collection tubestorage). The respective materials used for the tray, the cover and theadhesive (if utilized) can be sterile materials, e.g., materialsdesignated for medical usage.

The above presents a simplified summary in order to provide a basicunderstanding of some aspects of the systems and/or methods discussedherein. This summary is not an extensive overview of the systems and/ormethods discussed herein. It is not intended to identify key/criticalelements or to delineate the scope of such systems and/or methods. Itssole purpose is to present some concepts in a simplified form as aprelude to the more detailed description that is presented later.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A-1D illustrate views of an exemplary sterile fluid collectiontube package that includes a tray, a cover, and a fluid collection tube.

FIGS. 2A-2F illustrate views of another exemplary sterile fluidcollection tube package that includes a tray, a cover, and a pluralityof fluid collection tubes

FIGS. 3A-3C illustrate views of another exemplary sterile fluidcollection tube package.

FIGS. 4A-B illustrate views of another exemplary sterile fluidcollection tube package.

FIG. 5 illustrates an exemplary fluid collection tube.

DETAILED DESCRIPTION

Various technologies are presented herein pertaining to steriletransport, storage and operation of fluid collection tubes, wherein likereference numerals are used to refer to like elements throughout. In thefollowing description, for purposes of explanation, numerous specificdetails are set forth in order to provide a thorough understanding ofone or more aspects. It may be evident, however, that such aspect(s) maybe practiced without these specific details. In other instances,well-known structures and devices are shown in block diagram form inorder to facilitate describing one or more aspects.

Further, the term “or” is intended to mean an inclusive “or” rather thanan exclusive “or”. That is, unless specified otherwise, or clear fromthe context, the phrase “X employs A or B” is intended to mean any ofthe natural inclusive permutations. That is, the phrase “X employs A orB” is satisfied by any of the following instances: X employs A; Xemploys B; or X employs both A and B. In addition, the articles “a” and“an” as used in this application and the appended claims shouldgenerally be construed to mean “one or more” unless specified otherwiseor clear from the context to be directed to a singular form.Additionally, as used herein, the term “exemplary” is intended to meanserving as an illustration or example of something, and is not intendedto indicate a preference.

Sterile packaging and storage of fluid collection tubes can be importantfor collection tube usage in operatory rooms as well as in theprocessing of platelet-rich plasma (PRP), blood concentrates, growthfactors, platelet-rich fibrin (PRF), etc. For example, benefits canresult from using sterile packaging and storage of fluid collectiontubes that are employed when blood is collected from a patient,processed, and brought back to the patient's surgical sites or body.Hence, fluid collection tubes being sterile at time of usage can enhancean ability to obtain valid results and to further mitigate complicationsrelated to contamination.

Thus, as set forth herein, it is desired that fluid collection tubes(subsequently referred to herein as tube(s), collection tube(s), fluidcollection tube(s), retention tube(s), etc.) are maintained in a sterileatmosphere until use. However, owing to conventional packaging, aplurality of collection tubes are commonly supplied in a single package,such that upon opening the package to retrieve a collection tube, thetubes in the package, including unused tubes, are exposed to theatmosphere (e.g., in the laboratory) which can lead to undesirableconditions such as cross contamination. The various embodimentspresented herein enable packing and storage of one or more collectiontubes in a sterile configuration to avoid contamination (e.g., crosscontamination, airborne contamination, etc.) to minimize false resultsand provide protection against breakage, with a low inherent cost.

A plurality of embodiments are presented herein, which compared withconventional tube packaging and storage, can have the followingbenefits. The tubes contained in the packages are not restrictivelyheld, hence the tubes can be easily dispensed from the non-retentivepackage, e.g., in a sterile environment. In an embodiment, the packagecan be utilized for single use, e.g., once the sterile package is opened(e.g., cover removed) the tubes contained therein are utilized for asingle patient. The tray and cover comprising the package are formedwith medical grade materials to validate sterility.

FIGS. 1A-D present various perspective views illustrating a sterilefluid collection tube package 100 configured to store a fluid collectiontube 3. FIGS. 1A-1D collectively present a plurality of views of a tray1, a cover 2 (cover layer), and the fluid collection tube 3, wherein thefigures can be read in combination. The fluid collection tube 3 can be ablood collection tube, for example; however, it is contemplated thatother types of fluid collection tubes are intended to fall within thescope of the hereto appended claims. Moreover it is to be appreciatedthat other types of sample tubes can fall within the scope of theclaims, e.g., the fluid collection tube 3 can be a sample tube. FIG. 1Ais a top view illustrating a flange 4 of the tray 1 and an internalperspective of a cavity 5 formed therein. The flange 4 has an uppersurface 6. As shown, the cavity 5 is generally located centrally withinthe tray 1 with respect to the flange 4, such that the cavity 5 issurrounded by the flange 4. Hence, as shown in FIG. 1A, the flange 4forms a periphery of (e.g., acts as a boundary to) a central region,wherein the central region defines the cavity 5 surrounded by the flange4.

As further shown (e.g., FIGS. 1C and 1D), the cover 2 (e.g., a removablefilm) can be located on the tray 1 wherein a portion of the cover 2 isconfigured to attach to a portion 7 of the flange 4 such that the cavity5 is covered and sealed by the cover 2. The flange portion 7 can have aroughened surface to facilitate attachment to the cover 2, whereinattachment of the cover 2 to the tray 1 can be by any suitabletechnology, e.g., thermo-sealing, adhesive, etc. The roughened surfaceof the flange portion 7 can be formed by any suitable process, e.g.,patterning during the thermoforming process, a patterned injection mold,marking, abrasion, etc. The flange 4 can further have a smooth,non-rough portion 8 (e.g., a non-adhered portion), wherein the smoothportion 8 enables the cover 2 to be removed (e.g., peeled back) from thetray 1 to expose the fluid collection tube 3 stored therein (e.g., asshown in FIG. 1C). The rough portion 7 and the smooth portion 8 can belocated on the upper surface 6 of the flange 4.

The cavity 5 can be configured to retain (contain, locate, store) thefluid collection tube 3. The cavity 5 can be configured (e.g., formed)such that it comprises three portions: a central region C, a first endportion D, and a second end portion E, wherein the central region C islocated between the first end portion D and the second end portion E.Hence, as further described, the central region C, the first end portionD, and the second end portion E can be formed such that a trough-likecavity 5 is formed that can retain a fluid collection tube 3 locatedtherein, e.g., with or without application of the cover 2. The centralregion C can comprise a rectangular section 9 having a base wall 10, afirst sidewall 11, a second sidewall 12, a third sidewall 13, and afourth sidewall 14, wherein the first sidewall 11 and second sidewall 12are opposite, and the third sidewall 13 and the fourth sidewall 14 areopposite (e.g., a three dimensional cuboid, wherein one side forms anopening, such as a trough-like configuration). The base wall 10 isrecessed with respect to the upper surface 6 of the flange 4, and thefirst sidewall 11, the second sidewall 12, the third sidewall 13, andthe fourth sidewall 14 join the base wall 10 to the flange 4. The thirdsidewall 13 is proximally located to the smooth portion 8 of the flange4, while the fourth sidewall 14 is distally located from the smoothportion 8 of the flange 4 relative to the third sidewall 13.

The first end portion D and second end portion E respectively comprise afirst support recess 15 and a second support recess 16. The firstsupport recess 15 and the second support recess 16 are aligned along afirst common axis A-A and are respectively located about the rectangularsection 9 to form a first compartment comprising the first supportrecess 15, the rectangular section 9, and the second support recess 16.The first support recess 15 is located at a first junction 17 betweenthe flange 4 and the third sidewall 13, and the second support recess 16is located at a second junction 18 between the flange 4 and the fourthsidewall 14, as shown in FIG. 1D.

A first interior surface 19 of the first support recess 15 is concavewith respect to a plane B-B formed by the upper surface 6 of the flange4 (orientation of the plane B-B is shown in FIG. 1D), e.g., a radius ofcurvature of the interior surface 19 has a center located between theinterior surface 19 and the plane B-B. Accordingly, the first supportrecess 15 has a concavo-convex profile, wherein the interior surface 19is a concave surface and an exterior surface of the first support recess15 has a convex surface. A second interior surface 20 of the secondsupport recess 16 is concave with respect to the plane B-B formed by theupper surface 6 of the flange 4, e.g., a radius of curvature of theinterior surface 20 has a center located between the interior surface 20and the plane B-B. Accordingly, the second support recess 16 has aconcavo-convex profile, wherein the interior surface 20 is a concavesurface and an exterior surface of the second support recess 16 has aconvex surface. The plane B-B formed by the upper surface 6 of theflange 4 can be considered to be equivalent (e.g., similarly aligned) toa plane formed by the cover 2 when the cover 2 is attached to the tray 1(as shown in FIG. 1D).

As shown in FIG. 1B, the first support recess 15 terminates with a firstend wall 21, wherein the first end wall 21 joins the first supportrecess 15 with the flange 4, and the first end wall 21 is located at asecond end of the first support recess 15 that is opposite to a firstend of the first support recess 15 that adjoins to the sidewall 13. Asshown in FIG. 1A, the second support recess 16 terminates with a secondend wall 22, wherein the second end wall 22 joins the second supportrecess 16 with the flange 4, and the second end wall 21 is located at asecond end of the second support recess 16 that is opposite to a firstend of the second support recess 16 that adjoins to the sidewall 14.

As also shown in FIG. 1B, the flange 4 has a lower surface 23, whereinthe cavity 5 extends away from the lower surface 23 such that anexterior surface of the base wall 10 is located closer to the lowersurface 23 of the flange 4 in comparison to a distance between theexterior surface of the base wall 10 and the upper surface 6 of theflange 4.

The fluid collection tube 3 can comprise of a first end 24 (e.g., a cap,a stopper located in an open end of the tube 3) and a second end 25(e.g., a closed end of the tube 3), or vice versa. The tube 3 can belocated in the cavity 5, wherein the first end 24 of the tube 3 can belocated in the first support recess 15 and the second end 25 of the tube3 can be located in the second support recess 16.

Hence, as shown in FIG. 1D, the tube 3 (denoted by the dashed, hiddendetail line) is located in the cavity 5 formed by the centralrectangular section 9 in combination with the first support recess 15and the second support recess 16. The tube 3 is sealed in the cavity 5by the cover 2 attached to the upper surface 6 of the flange 4 to coverover the cavity 5. The tube 3 has a length and a width, wherein thecavity 5 comprising the first support recess 15, the second supportrecess 16, and the central rectangular section 9 has a length having adimension longer than the length of the tube, and further, the firstsupport recess 15, the second support recess 16, and the centralrectangular section 9 have a width (diameter) greater than the width ofthe tube 3. As shown in FIG. 1D, with the tube 3 located in the cavity 5of the tray 1, and the cover 2 located over the cavity 5 and attached tothe flange portion 7, the tube 3 is retained in a sterile atmospherecreated by enclosing the tube 3 in a volume of gas (e.g., air,sterilized air, or other gas), wherein the volume of gas is defined bythe volume created by the cavity 5 and the cover 2 located thereon. Inan embodiment, the sterile fluid collection tube package 100, includingthe tray 1, the cover 2, and the fluid collection tube(s) 3 can besterilized, e.g., by irradiating with gamma radiation, or other suitablesterilizing technique. Such sterilization can cause the volume of gas inthe cavity 5 to also be sterilized.

The tray 1, and cavity 5 formed therein, can be formed by any suitableprocess. In an embodiment, the tray 1 can be thermoformed from sheetstock, e.g., the recessed cavity 5 is thermoformed in the sheet stock,wherein the non-deformed region of the sheet stock can form the flange4. In another embodiment, the tray 1 can be formed by an injectionmolding process. The tray 1 can be formed from any suitable material,wherein the material is a sterile material (e.g., is rated as suitablefor medically sterile applications, is rated as suitable for a medicalapplication, etc.). The material for the tray 1 can, in a non-limitinglist, include any of a synthetic resin, a sterile foam, a thermoplastic,a polymer, polyurethane, polyethylene terephthalate (PET), polyvinylchloride (PVC), polyester, etc. The tray 1 can be formed from materialthat is resiliently deformable, to minimize impact on the one or morecollection tubes 3 located therein. The tray 1 can be formed from sheetmaterial having any desired thickness (e.g., as based upon a desiredwall thickness and/or dimension of any of the thermoformed base wall 10,the first sidewall 11, the second sidewall 12, the third sidewall 13,and/or the fourth sidewall 14). In an embodiment the sheet material canhave a minimum thickness of about 0.4 mm (e.g., about 0.015″). Inanother embodiment, the sheet material can have a thickness of about 0.5mm (e.g., about 0.02″). In another embodiment the sheet material canhave a thickness in the range of about 0.4 mm to about 0.8 mm (e.g.,about 0.015″ to about 0.0315″). In a further embodiment, the sheetmaterial can have a thickness of greater than about 0.8 mm (e.g., about0.0315″). In another embodiment, the sheet material can have a minimumthickness of 0.4 mm and greater than 0.8 mm (e.g., about 0.015″to >0.0315″). The thicknesses presented here can also be applied to awall thickness(es) of a tray 1 that has been formed by injectionmolding.

The cover 2 can comprise any suitable material, wherein the material issterile (e.g., is rated as suitable for medically sterile applications).The material for the cover 2 can, in a non-limiting list, include atleast one of paper, reinforced paper, synthetic reinforced paper,polyethylene terephthalate (PET), polyethylene terephthalateglycol-modified (PET-G), amorphous PET (A-PET), recycled PEI′ (rPET),high impact polystyrene (HIPS), polyvinyl chloride (PVC), polyethylene(PE), high density PE, polypropylene (PP), metal foil, TYVEK, TYVEK 2FS,BAREX, TRITON, etc. Further, any suitable bonding process can beutilized to attach the cover 2 to the flange 4 of the tray, e.g.,thereto-bonding, adhesive, etc, In the event of an adhesive beingutilized, the adhesive (not shown) can have a composition to enable thecover 2 to be resealed to the tray 1 after removal of the one or morecollection tubes 3 located therein. The respective thicknesses of thetray 1 and the cover 2 can be of any desired value. The cover 2 can beformed from sheet material having any desired thickness to facilitatesealing of the cavity 5, and the tube(s) 3 located therein. In anembodiment the sheet material can have a thickness of about0.0028-0.0092″ mils (about 70-230 microns). In another embodiment, thesheet material can have an average thickness of about 0.00598″ mils(about 152 microns).

As shown in FIG. 1C, the cover 2 can include a data region, e.g., alabel 26, wherein the label 26 can provide information such as branding(e.g., manufacturer of the tube 3, a type of tube 3, manufacturer of thepackage 100, manufacturer of the tray 1, manufacturer of the cover 2,etc.), technical information, traceability information, etc. The label26 can be printed on, or attached to, the cover 2, wherein the label 26can be of any suitable form, e.g., alphanumeric information, a barcode,a hologram, etc.

As previously mentioned, a tray can be configured to store more than onecollection tube. FIGS. 2A-2F present various perspective viewsillustrating a sterile fluid collection tube package 200 configured tostore two or more fluid collection tubes. In the example depicted inFIGS. 2A-2F, the sterile fluid collection tube package 200 stores sixfluid collection tubes; however, it is contemplated that substantiallyany number of fluid collection tubes are intended to fall within thescope of the hereto appended claims.

FIGS. 2A-2F collectively present a plurality of views of a tray 31, acover 32, and a plurality of fluid collection tubes 33A-n (where n is apositive integer), wherein the figures can be read in combination. FIG.2A is a top view illustrating a flange 34 of the tray 31 and an internalperspective of a cavity 35 formed therein. The flange 34 has an uppersurface 36. As shown, the cavity 35 is generally located centrallywithin the tray 31, such that the cavity 35 is surrounded by the flange34.

The various components and features presented in FIGS. 2A-2F are similarto respective components and features described in FIGS. 1A-1D. Forexample, the tray 31 can be formed using the same processes andmaterials as tray 1, the cover 32 can be formed using the same processesand materials as cover 2, and the fluid collection tubes 33 can beformed from the same processes and materials as collection tube 3.

As shown in FIG. 2C, and as previously described with reference to FIGS.1A-1D, the cover 32 can be located on the tray 31 wherein a portion ofthe cover 32 is configured to attach to a portion 37 of the flange 34such that the cavity 35 is covered and sealed by the cover 32. Theflange portion 37 can have a roughened surface to facilitate attachmentto the cover 32, wherein attachment can be via any suitable operation,e.g., the cover 32 is thermo-sealed to the tray 31. The flange 34 canfurther have a smooth, non-rough portion 38 (e.g., non-adhered portion),wherein the smooth portion 38 enables the cover 32 to be removed fromthe tray 31 to expose collection tubes 33A-n stored therein. The roughportion 37 and the smooth portion 38 can be located on the upper surface36 of the flange 34.

As previously described with reference to FIGS. 1A-1D, the cavity 5 canbe formed with a single compartment comprising the rectangular section 9located between the first support recess 15 and the second supportrecess 16. As shown in FIGS. 2A-2F, to facilitate storage of a pluralityof collection tubes 33A-n, the cavity 35 can be formed comprising aplurality of compartments. The cavity 35 can be formed with a centralrectangular section 39 located between a first plurality of firstsupport recesses 45A-n and a second plurality of second support recesses46A-n, wherein the number n of first support recesses 45 and the numbern of second support recesses 46 is equivalent to the number n ofcollection tubes 33A-n to be stored therein. The cavity 35 comprising aplurality of compartments can be considered to be formed from aplurality of co-joined single compartments, wherein a single compartmentforms the cavity 5 of FIG. 1A.

The rectangular section 39 has a base wall 40, a first sidewall 41, asecond sidewall 42, a third sidewall 43, and a fourth sidewall 44,wherein the first sidewall 41 and second sidewall 42 are opposite, andthe third sidewall 43 and the fourth sidewall 44 are opposite (e.g., therectangular section 39 has a trough-like configuration). The base wall40 is recessed with respect to the upper surface 36 of the flange 34,and the first sidewall 41, the second sidewall 42, the third sidewall43, and the fourth sidewall 44 join the base wall 40 to the flange 34.The third sidewall 43 is proximally located to the smooth portion 38 ofthe flange 34, while the fourth sidewall 44 is distally located from thesmooth portion 38 of the flange 34 relative to the third sidewall 43.

As shown in FIG. 2B, respective pairs of first support recesses andsecond support recesses are aligned along a common axis. For example, afirst pair of support recesses comprising a first support recess 45A anda second support recess 46A are aligned along a common axis X-X, asecond pair of support recesses comprising a third support recess 45Band a fourth support recess 46B are aligned along a common axis Y-Y,etc. Each respective pair of first support recesses and second supportrecesses, in conjunction with a respective portion of the rectangularsection 39 located between each respective pair of first supportrecesses and second support recesses, form a compartment (a channel).Hence, the first support recess 45A and the second support recess 46A,in conjunction with a first portion of the rectangular section 39 form afirst compartment to store a first a separating wall 60 separates thefirst support recess 45A and the third support recess 45B collectiontube 33A, the third support recess 45B and the fourth support recess46B, in conjunction with a second portion of the rectangular section 39form a second compartment to store a second collection tube 33B, then^(th) support recess 45 n and the n^(th)+1 support recess 46 n, inconjunction with a second portion of the rectangular section 39 form ann^(th) compartment to store a n^(th) collection tube 33 n.

The respective interior surfaces of the support recesses 45A-45 n and46A-46 n are concave with respect to a plane P-P formed by the uppersurface 36 of the flange 34 (orientation of the plane P-P is shown inFIG. 2D), as previously described with regard to support recesses 15 and16, accordingly the support recesses 45A-n and 46A-n have aconcavo-convex profile. Separating walls (ridges) are located betweenadjacent compartments, e.g., as shown in FIG. 2A, a first separatingwall 60 separates the first support recess 45A and the third supportrecess 45B, a second separating wall 61 separates the second supportrecess 46A and the fourth support recess 46B. The first separating wall60 and the second separating wall 61 are aligned along a common axisZ-Z, wherein the axis Z-Z is parallel to the axis X-X and the axis Y-Y.With respect to the support recesses 45A-45 n and 46A-46 n having aconcavo-convex profile with regard to plane P-P, in an embodiment, theseparating walls 60 and 61 have a concavo-convex profile such that theseparating wall in conjunction with the walls of the adjacent supportrecesses has a serpentine profile. In another embodiment, the separatingwalls 60 and 61 have a flat profile.

Further, as previously described, a first end of each respective supportrecess forms a junction with a respective sidewall that it adjoins(e.g., per the configuration presented in FIGS. 1A-1D, a first end ofthe first support recess 15 is located at a first junction 17 betweenthe flange 4 and the third sidewall 13, and the first end of the secondsupport recess 16 is located at a second junction 18 between the flange4 and the fourth sidewall 14.). Hence, a first end of the first supportrecess 45 n is located at a first junction 47 between the flange 34 andthe third sidewall 43 (per FIG. 2B), and a first end of the secondsupport recess 46 n is located at a second junction 48 between theflange 34 and the fourth sidewall 44 (per FIG. 2A).

As shown in FIG. 2B, the flange 34 has a lower surface 49, wherein thecavity 35 extends away from the lower surface 49 such that an exteriorsurface of the base wall 40 is located closer to the lower surface 49 ofthe flange 34 in comparison to a distance between the exterior surfaceof the base wall 40 and the upper surface 36 of the flange 34.Furthermore, as shown in FIGS. 2A and 2B, each support recess terminateswith an end wall, wherein the end wall connects a second end of asupport recess with the flange 34. A first end wall 70 connects thesecond end of each respective first support recess 45A-n to the flange34, wherein the first end wall 70 forms a first junction 71 with theunderside surface 49 of the flange 34. A second end wall 72 connects thesecond end of each respective second support recess 46A-n to the flange34, wherein the first end wall 72 forms a first junction 73 with theunderside surface 49 of the flange 34.

The tubes 33A-n can respectively comprise of first end (e.g., a cap, astopper located in an open end of the tube) and a second end (e.g., aclosed end of the tube), or vice versa. Per FIG. 2F, a plurality oftubes 33A-n are located in the tray 31, wherein tube 33A has a first end54A and a second end 55A. The tubes 33A-n can be located in the cavity35, wherein the tube 33A is located in the first compartment formedbetween the first support recess 45A and the second support recess 46A,the tube 33B is located in the second compartment formed between thethird support recess 45B and the fourth support recess 46B, etc.

FIG. 2F illustrates a plurality of tubes 33A-n located in the tray 31,tube 33A is located in the support recesses 54A and 55A, tube 33B islocated in the support recesses 54B and 55B, wherein the tubes areseparated by both the respective support recesses and the respectiveseparating walls 60 and 61. As shown in FIG. 2C, the tubes 33A-n aresealed in the cavity 35 by the cover 32 attached to the upper surface 36of the flange 34 to cover over the cavity 35.

As further shown in FIG. 2F, the cover 32 can include a data region,e.g., a label 65, wherein the label 65 can be of the form, and includeinformation, as previously described for the label 26.

FIGS. 3A-C are a perspective views of another exemplary sterilecollection tube package 300. As shown, the previously described trays(e.g., tray 1 and tray 31) have been configured as a box-like tray 71,having exterior flat rectangular side walls and a flat exterior basewith interior round openings so that the tubes will be held in avertical position. A cover 72 is shown, and further, a plurality oftubes 73. It is to be appreciated that while six tubes 73 areillustrated, the tray 71 can be formed for a required n number of tubes73. Accordingly, a number of round openings will vary for the box tray71 designed to hold different number of collection tubes 73, forexample, the box-like tray 71 designed to hold eight collection tubes 73will have eight round openings (not illustrated). FIG. 3A illustratessix collection tubes 73 prior to being placed inside the box tray 71.FIG. 3B illustrates the collection tubes 73 placed inside the box. Anupper flange 74 of the box tray 73 is a flat surface rectangular shape(e.g., similar to flange 4 and flange 34), configured with an adhesivemarks portion 77 to enable sealing engagement with the cover 72 and asmooth portion 74 without adhesive marking to enable easy peel removalof the cover 72 from the flange 74. FIG. 3C illustrates the cover 72attached to the flange 74, and further a label 80 incorporated into thecover 72. The box tray 71 can be fabricated by the same process as tray1, and further the box tray 71 can be formed from the same materials astray 1. The cover 72 can be fabricated by the same process as cover 2,and further the cover 72 can be formed from the same materials as cover2. The label 80 can be formed and function the same as the previouslydescribed label 26.

FIGS. 4A and 4B illustrates an alternative embodiment for the flangethat surrounds the central cavity region. As shown in FIGS. 1-3, therespective smooth portions of the flange (e.g., respective regions 8,38, 78) are illustrated as being in the same plane as the roughenedregions (e.g., regions 7, 37, 77) of the flange at which the respectivecover (e.g., cover 2, 32, 72) is attached (e.g., by thermo-bonding). Forexample, the flange smooth portions illustrated in FIGS. 1-3 are alignedin the same plane (e.g., plane B-B, plane P-P) as the respectiveroughened portions. FIGS. 4A and 4B illustrate a tray 91, to which acover 92 can be attached, to enable sterile storage of a plurality oftubes 93 therein. While only two tubes 93 are illustrated, the tray 91can be configured to store 1-n tubes, as previously described. As shown,an interface at which the cover 92 and the roughened portion 98 of theflange 91 are attached can be aligned along the plane K-K. Further, anend portion 97 of the flange 91 can be offset from plane K-K, whereinthe end portion 97 is aligned along a plane J-J, wherein planes K-K andJ-J have different alignments and/or orientations. Accordingly, while afirst portion CP1 of the cover 2 is attached to the roughened portion98, a second portion CP2 of the cover 2 is not attached to the offsetflange end portion 97, such that an upper surface 99 of the end portion97 on the plane J-J is located at a separation distance SD from theplane K-K.

While not illustrated, it is to be appreciated that the one or more trayconfigurations presented herein (e.g., tray 1, tray 31, tray 71) can beformed without one or more sidewalls being formed (e.g., any of thesidewall 11, the sidewall 12, the sidewall 13, the sidewall 14, base 10,the sidewall 41, the sidewall 42, the sidewall 43, the sidewall 44, thebase 40, etc.), wherein the tray (with or without a cover) can be sealedinside a double or triple medical grade sealed bag.

FIG. 5 illustrates a configuration 500 with a collection tube that hasbeen sealed with a cap and a hood. The collection tube 3 has a closedend 25 and an open end that is sealed with a cap 24 (as previouslydescribed). A hood 510 has been placed over the cap 24 and a portion ofa length of the tube 3, wherein the hood 510 is configured to supplementthe cap 24 in sealing a sample 520 in the tube 3. The hood 510 can beformed from a flexible, elastic material formulated to prevent leakageof air into and/or out of the tube 3, wherein such air leakage couldcontaminate the sample 520. The hood 510 can also be utilized with atube 3 and cap 24 that does not have a sample 520 placed therein. Thedimensioning of the cavity 5 (e.g., the width of the first recess 15)can be configured to accommodate a tube 3 sealed with a cap 24 and thehood 510.

Various examples are now set forth.

Example 1

A sterile fluid collection tube package, comprising: a fluid collectiontube having first end and a second end; a thermoformed tray formed froma first sterile material, the thermoformed tray comprising a flangehaving an upper surface, and a central region, wherein the centralregion defines a cavity surrounded by the flange, the cavity comprising:a recessed portion comprising a rectangular section having a base wall,a first sidewall, a second sidewall, a third sidewall, and a fourthsidewall, the first sidewall and second sidewall are opposite, and thethird sidewall and the fourth sidewall are opposite, the base wall isrecessed with respect to the upper surface of the flange, and the firstsidewall, the second sidewall, the third sidewall, and the fourthsidewall join the base wall to the flange; a first support recess and asecond support recess, the first support recess and the second supportrecess are aligned along a first common axis and are respectivelylocated about the recessed portion to form a first compartment, whereinthe first support recess is located at a first junction between theflange and the third sidewall, and the second support recess is locatedat a second junction between the flange and the fourth sidewall, a firstinterior surface of the first support recess is convex with respect to aplane formed by the upper surface of the flange and a second interiorsurface of the second support recess is convex with respect to the planeformed by the upper surface of the flange, wherein the fluid collectiontube is located in the cavity, the first end of the fluid collectiontube is located in the first support recess and the second end of thefluid collection tube is located in the second support recess; and acover formed from a second sterile material, the cover is attached tothe upper surface of the flange, wherein the cover is sized to cover anentirety of the cavity and the fluid collection tube located therein.

Example 2

The sterile fluid collection tube package according to Example 1,wherein the first sterile material is one of a synthetic resin, asterile foam, polyurethane, polyethylene terephthalate (PET), polyvinylchloride (PVC), or polyester.

Example 3

The sterile fluid collection tube package according to any of Examples1-2, wherein the second sterile material comprises at least one ofpaper, reinforced paper, synthetic reinforced paper, polyethyleneterephthalate (PET), polyethylene terephthalate glycol-modified (PET-G),amorphous PET (A-PET), recycled PET (rPET), high impact polystyrene(HIPS), polyvinyl chloride (PVC), polyethylene (PE), high density PE,polypropylene (PP), metal foil, TYVEK, TYVEK 2FS, BAREX, or TRITON.

Example 4

The sterile fluid collection tube package according to any of Examples1-3, further comprising a releasable adhesive, wherein the cover isattached to the upper surface of the flange by the releasable adhesive,and the releasable adhesive facilitates removal of the cover from thethermoformed tray.

Example 5

The sterile fluid collection tube package according to any of Examples1-4, wherein: the first support recess opens into the recessed portion,the first support recess further comprising a first end wall, a firstedge of the first end wall adjoins the flange, and a second edge of thefirst end wall follows a convex profile of the first interior surface ofthe first support recess; and the second support recess opens into therecessed portion, the second support recess further comprising a secondend wall, a third edge of the second end wall adjoins the flange, and afourth edge of the second wall follows a convex profile of the secondinterior surface of the second support recess.

Example 6

The sterile fluid collection tube package according to any of Examples1-5, wherein the thermoformed tray is formed from a sheet of the sterilethermoplastic, the sheet having a thickness in a range between 4 mm and8 mm.

Example 7

The sterile fluid collection tube package according to any of Examples1-6, wherein the fluid collection tube has a length and a width, whereinthe first support recess, the second support recess, and a first portionof the recessed portion are dimensioned such that the fluid collectiontube is located in a compartment formed by the first support recess, thesecond support recess, and the first portion of the recessed portion.

Example 8

The sterile fluid collection tube package according to any of Examples1-7, further comprising a third support recess and a fourth supportrecess, the third support recess and the fourth support recess arealigned along a second common axis and are respectively located aboutthe recessed portion to form a second compartment, the first common axisand the second common axis are substantially parallel, wherein the thirdsupport recess is located at a third junction between the flange and thethird sidewall, and the fourth support recess is located at a fourthjunction between the flange and the fourth sidewall, a third interiorsurface of the third support recess is convex with respect to the planeformed by the upper surface of the flange and a fourth interior surfaceof the fourth support recess is convex with respect to the plane formedby the upper surface of the flange, wherein a second fluid collectiontube is located in the second compartment.

Example 9

The sterile fluid collection tube package according to any of Examples1-8, wherein the fluid collection tube is a blood collection tube.

Example 10

A package configured to retain at least one sample tube, the packagecomprising: a tray comprising a flange surrounding a recessed portion,wherein the tray is formed from a sterile thermoplastic, the recessedportion of the tray comprising: a rectangular section having a basewall, a first sidewall, a second sidewall, a third sidewall, and afourth sidewall, the first sidewall and second sidewall are opposite,and the third sidewall and the fourth sidewall are opposite, and thefirst sidewall, the second sidewall, the third sidewall, and the fourthsidewall join the base wall to the flange; and a first compartment,wherein the first compartment is configured to receive a first sampletube, the first compartment comprising a first support recess and asecond support recess, the first support recess has a first length andthe second support recess has a second length, wherein the first lengthand the second length are aligned along a first common axis and arerespectively located about the rectangular section, wherein: a fifthsidewall extending along the first length of the first support recess isconcavo-convex with respect to a plane formed by the flange, a first endof the first support recess is located at a first junction between theflange and the third sidewall and opens into the rectangular section, asecond end of the first support recess connects the fifth sidewall tothe flange; and a sixth sidewall extending along the second length ofthe second support recess is concavo-convex with respect to the planeformed by the flange, a third end of the second support recess islocated at a second junction between the flange and the fourth sidewalland opens into the rectangular section, a fourth end of the secondsupport recess connects the sixth sidewall to the flange.

Example 11

The package according to Example 10, wherein the sterile thermoplasticis one of a synthetic resin, a sterile foam, a polyurethane film,polyethylene terephthalate (PET), polyvinyl chloride (PVC), orpolyester.

Example 12

The package according to any of Examples 10 and 11, wherein the tray isformed from a sheet of the sterile thermoplastic, the sheet having athickness in a range between 4 mm and 8 mm.

Example 13

The package according to any of Examples 10-12, further comprising acover formed from a sterile material, the cover is attached to an uppersurface of the flange, wherein the cover is sized to cover an entiretyof the recessed portion of the tray.

Example 14

The package according to any of Examples 10-13, wherein the sterilematerial comprises at least one of paper, a reinforced paper, asynthetic reinforced paper, polyethylene terephthalate (PET),polyethylene terephthalate glycol-modified (PET-G), amorphous PET(A-PET), recycled PET (rPET), high impact polystyrene (HIPS), polyvinylchloride (PVC), polyethylene (PE), high density PE, polypropylene (PP),metal foil, TYVEK, TYVEK 2FS, BAREX, or TRITON.

Example 15

The package according to any of Examples 10-14, further comprising areleasable adhesive, wherein the cover is attached to the upper surfaceof the flange by the releasable adhesive, and the releasable adhesivefacilitates removal of the cover from the tray.

Example 16

The package according to any of Examples 10-15, further comprising thefirst sample tube, wherein the first compartment is configured to storethe first sample tube, dimensioning of the first compartment is suchthat the first sample tube can be located within the first compartment.

Example 17

The package according to any of Examples 10-16, wherein the sample tubeis a blood collection tube.

Example 18

The package according to any of Examples 10-17, wherein the tray isformed by injection molding the sterile thermoplastic.

Example 19

The package according to any of Examples 10-18, further comprising alabel, wherein the label comprises at least one of brand information,technical information, or traceability information.

Example 20

A package configured to retain a fluid collection tube, the packagecomprising: a means for storing the fluid collection tube in a sterileenvironment, and a means for covering the fluid collection tube in thesterile environment.

What has been described above includes examples of one or moreembodiments. It is, of course, not possible to describe everyconceivable modification and alteration of the above structures ormethodologies for purposes of describing the aforementioned aspects, butone of ordinary skill in the art can recognize that many furthermodifications and permutations of various aspects are possible.Accordingly, the described aspects are intended to embrace all suchalterations, modifications, and variations that fall within the spiritand scope of the appended claims. Furthermore, to the extent that theterm “includes” is used in either the details description or the claims,such term is intended to be inclusive in a manner similar to the term“comprising” as “comprising” is interpreted when employed as atransitional word in a claim.

What is claimed is:
 1. A sterile fluid collection tube package,comprising: a fluid collection tube having a first end and a second end;a thermoformed tray formed from a first sterile material, wherein thethermoformed tray includes a flange having an upper surface and acentral region, wherein the central region defines a cavity surroundedby the flange, wherein the cavity comprises: a recessed portioncomprising a base wall and a sidewall, wherein the base wall is recessedwith respect to the upper surface of the flange, wherein the sidewalljoins the base wall to the flange; and a first support recess and asecond support recess, wherein the first support recess and the secondsupport recess are aligned along a common axis, wherein the firstsupport recess and the second support recess are located at opposingportions of the recessed portion to form a compartment, wherein thefirst support recess is located at a first junction between the flangeand the sidewall, wherein the second support recess is located at asecond junction between the flange and the sidewall, wherein the fluidcollection tube is located in the cavity, wherein the first end of thefluid collection tube is located in the first support recess and thesecond end of the fluid collection tube is located in the second supportrecess; and a seal system formed from a second sterile materialconfigured to seal the cavity and the fluid collection tube locatedtherein in a sterile environment.
 2. The sterile fluid collection tubepackage of claim 1, wherein the seal system comprises a medical gradebag.
 3. The sterile fluid collection tube package of claim 1, whereinthe seal system comprises a cover attached to the upper surface of theflange, wherein the cover is sized to cover an entirety of the cavity.4. The sterile fluid collection tube package of claim 3, furthercomprising a releasable adhesive, wherein the cover is attached to theupper surface of the flange by the releasable adhesive, and thereleasable adhesive facilitates removal of the cover from thethermoformed tray
 5. The sterile fluid collection tube package of claim1, wherein the sterile material is one of a synthetic resin, a sterilefoam, polyurethane, polyethylene terephthalate (PET), polyvinyl chloride(PVC), or polyester.
 6. The sterile fluid collection tube package ofclaim 1, wherein the thermoformed tray is formed from a sheet of thesterile thermoplastic, the sheet having a thickness in a range between 4mm and 8 mm.
 7. The sterile fluid collection tube package of claim 1,wherein the second sterile material is different from the first sterilematerial.
 8. The sterile fluid collection tube package of claim 1,wherein the second sterile material comprises at least one of paper,reinforced paper, synthetic reinforced paper, polyethylene terephthalate(PET), polyethylene terephthalate glycol-modified (PET-G), amorphous PET(A-PET), recycled PET (rPET), high impact polystyrene (HIPS), polyvinylchloride (PVC), polyethylene (PE), high density PE, polypropylene (PP),metal foil, TYVEK, TYVEK 2FS, BAREX, or TRITON.
 9. The sterile fluidcollection tube package of claim 1, wherein the base wall has arectangular shape, wherein a plurality of sidewalls connect the basewall to the flange, wherein the sidewall is in the plurality ofsidewalls.
 10. The sterile fluid collection tube package of claim 1,further comprising a third support recess and a fourth support recess,wherein the third support recess and the fourth support recess arealigned along a second common axis, wherein the third support recess andthe fourth support recess are located at opposing portions of therecessed portion to form a second compartment, wherein the third supportrecess is located at a third junction between the flange and thesidewall, wherein the fourth support recess is located at a fourthjunction between the flange and the sidewall, wherein a second fluidcollection tube is located in the second cavity, wherein a first end ofthe second fluid collection tube is located in the third support recessand a second end of the second fluid collection tube is located in thefourth support recess.
 11. The sterile fluid collection tube package ofclaim 10, wherein the third support recess is adjacent the first supportrecess and the fourth support recess is adjacent the second supportrecess, wherein a first separating wall separates the first supportrecess and the third support recess, wherein a second separating wallseparates the second support recess and the fourth support recess. 12.The sterile fluid collection tube package of claim 1, wherein the fluidcollection tube is a blood collection tube.
 13. A package configured toretain at least one sample tube, the package comprising: a traycomprising a flange surrounding a recessed portion, wherein the tray isformed from a sterile thermoplastic, the recessed portion of the traycomprising: a recessed portion comprising a base wall and a sidewall,wherein the base wall is recessed with respect to the upper surface ofthe flange, wherein the sidewall joins the base wall to the flange; afirst compartment, wherein the first compartment is configured toreceive a first fluid collection tube, the first compartment comprisinga first support recess and a second support recess, the first supportrecess has a first length and the second support recess has a secondlength, wherein the first length and the second length are aligned alonga first common axis and are respectively located at opposing portions ofthe recessed portion, wherein the first support recess comprises asecond base wall extending along the first length of the first supportrecess, wherein the second base wall is recessed with respect to theupper surface of the flange and the second base wall is offset withrespect to the base wall of the recessed portion, wherein a secondsidewall joins the second base wall to the flange, wherein the secondsupport recess comprises a third base wall extending along the secondlength of the second support recess, wherein the third base wall isrecessed with respect to upper surface of the flange and the third basewall is offset with respect to the base wall of the recessed portion,wherein a third sidewall joins the third base wall to the flange. 14.The package of claim 13, wherein at least one of the second base wall orthe third base wall is concavo-convex with respect to a plane formed bythe flange.
 15. The package of claim 13, wherein the sterilethermoplastic is one of a synthetic resin, a sterile foam, apolyurethane film, polyethylene terephthalate (PET), polyvinyl chloride(PVC), or polyester.
 16. The package of claim 13, further comprising asealing system formed from a second sterile material configured to sealthe recessed portion in a sterile environment.
 17. The package of claim16, wherein the second sterile material comprises at least one of paper,a reinforced paper, a synthetic reinforced paper, polyethyleneterephthalate (PET), polyethylene terephthalate glycol-modified (PET-G),amorphous PET (A-PET), recycled PET (rPET), high impact polystyrene(HIPS), polyvinyl chloride (PVC), polyethylene (PE), high density PE,polypropylene (PP), metal foil, TYVEK, TYVEK 2FS, BAREX, or TRITON. 18.The package of claim 13, further comprising a second compartment,wherein the second compartment is configured to receive a second sampletube, the second compartment comprising a third support recess and afourth support recess, the third support recess has a third length andthe fourth support recess has a fourth length, wherein the third lengthand the fourth length are aligned along a first common axis and arerespectively located at opposing portions of the recessed portion,wherein the third support recess comprises a third base wall extendingalong the third length of the third support recess, wherein the thirdbase wall is recessed with respect to the upper surface of the flangeand the third base wall is raised with respect to the base wall of therecessed portion, wherein a fourth sidewall joins the third base wall tothe flange, wherein the fourth support recess comprises a fourth basewall extending along the fourth length of the fourth support recess,wherein the fourth base wall is recessed with respect to upper surfaceof the flange and the fourth base wall is raised with respect to thebase wall of the recessed portion, wherein a fifth sidewall joins thefourth base wall to the flange.
 19. A sterile fluid collection tubepackage, comprising: a first fluid collection tube having a first endand a second end; a second fluid collection tube having a third end anda fourth end; a thermoformed tray formed from a first sterile material,wherein the thermoformed tray includes a flange having an upper surfaceand a central region, wherein the central region defines a cavitysurrounded by the flange, wherein the cavity comprises: a recessedportion comprising a base wall and a sidewall, wherein the base wall isrecessed with respect to the upper surface of the flange, wherein thesidewall joins the base wall to the flange; a first compartment, whereinthe first compartment is configured to receive the first fluidcollection tube, the first compartment comprising a first support recessand a second support recess, the first support recess has a first lengthand the second support recess has a second length, wherein the firstlength and the second length are aligned along a first common axis andare respectively located at opposing portions of the recessed portion,wherein the first support recess is located at a first junction betweenthe flange and the sidewall, wherein the second support recess islocated at a second junction between the flange and the sidewall,wherein the fluid collection tube is located in the cavity, wherein thefirst end of the fluid collection tube is located in the first supportrecess and the second end of the fluid collection tube is located in thesecond support recess; a second compartment, wherein the secondcompartment is configured to receive the second fluid collection tube,the second compartment comprising a third support recess and a fourthsupport recess, the third support recess has a third length and thefourth support recess has a fourth length, wherein the third length andthe fourth length are aligned along a second common axis and arerespectively located at opposing portions of the recessed portion,wherein the third support recess is located at a third junction betweenthe flange and the sidewall, wherein the fourth support recess islocated at a fourth junction between the flange and the sidewall,wherein the fluid collection tube is located in the cavity, wherein thethird end of the fluid collection tube is located in the third supportrecess and the fourth end of the fluid collection tube is located in thesecond support recess; and a seal system formed from a second sterilematerial configured to seal the cavity and the fluid collection tubelocated therein in a sterile environment.
 20. The sterile fluidcollection tube package of claim 19, wherein the third support recess isadjacent the first support recess and the fourth support recess isadjacent the second support recess, wherein a first separating wallseparates the first support recess and the third support recess, whereina second separating wall separates the second support recess and thefourth support recess.